Transapical transcatheter aortic valve replacement in bicuspid aortic valve patients: In-hospital outcomes_Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

Authors：

HUANG Xuan ^1,2 , LIU Lulu ³ , ZHU Tingxi ^1,2 , LI Kehan ⁴ ,  GUO Yingqiang ³ ,  YANG Xiaoyan ^1,2

1. West China Biomedical Big Data Center, West China Hospital/West China School of Medicine, Sichuan University, Chengdu, 610041, P. R. China;
2. Med-X Center for Informatics, Sichuan University, Chengdu, 610041, P. R. China;
3. Department of Cardiovascular Surgery, West China Hospital, Sichuan University, Chengdu, 610041, P. R. China;
4. West China School of Public Health and West China Fourth Hospital, Sichuan University, Chengdu, 610041, P. R. China;

Corresponding author：

GUO Yingqiang, Email: drguoyq@hotmail.com; YANG Xiaoyan, Email: yangxiaoyan@scu.edu.cn

Keywords：

Transapical transcatheter aortic valve replacement; bicuspid aortic valve; transapical approach; J-Valve^TM; aortic valve disease

DOI：

10.7507/1007-4848.202211038

Video：

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Objective To compare the in-hospital outcomes of transapical transcatheter aortic valve replacement (TA-TAVR) for bicuspid aortic valve (BAV) patients and tricuspid aortic valve (TAV) patients. Methods Patients (including BAV and TAV patients) who underwent TA-TAVR with the J-Valve^TM in West China Hospital from July 2014 to July 2020 were included consecutively. The clinical outcomes of the patients were analyzed. Results A total of 354 patients were included in the study, 75 in the BAV group and 279 in the TAV group. There were 229 males and 125 females with a mean age of 72.2±6.0 years. No death occurred during the procedure, and the overall technical success rate was 97.7%. The all-cause in-hospital mortality rate was 1.4%. Twenty (26.7%) patients with BAV and 46 (16.5%) patients with TAV had mild or higher perivalvular leaks immediately after the procedure. No patients with BAV required permanent pacemaker implantation postoperatively, while 13 (4.7%) TAV patients required permanent pacemaker implantation, with an overall pacemaker implantation rate of 3.7%. One (1.3%) BAV patient and 7 (2.5%) TAV patients developed acute kidney injury postoperatively. One (1.3%) BAV patient and 1 (0.4%) TAV patient developed perioperative myocardial infarction. The average postoperative hospital stay was 7.6±3.6 d for BAV patients and 8.6±6.1 d for TAV patients. There was no statistical difference in primary or secondary in-hospital outcomes between BAV and TAV patients (P>0.05). Conclusion Compared to TAV patients, BAV patients have similar in-hospital outcomes, with a low incidence of adverse clinical outcomes, which provides preliminary evidence for its implementation in Chinese patients with a high proportion of BAV.

Citation： HUANG Xuan, LIU Lulu, ZHU Tingxi, LI Kehan, GUO Yingqiang, YANG Xiaoyan. Transapical transcatheter aortic valve replacement in bicuspid aortic valve patients: In-hospital outcomes. Chinese Journal of Clinical Thoracic and Cardiovascular Surgery, 2023, 30(8): 1128-1136. doi: 10.7507/1007-4848.202211038 Copy

1.	Leon MB, Smith CR, Mack MJ, et al. Transcatheter or surgical aortic-valve replacement in intermediate-risk patients. N Engl J Med, 2016, 374(17): 1609-1620.
2.	Reardon MJ, Mieghem NM, Popma JJ, et al. Surgical or transcatheter aortic-valve replacement in intermediate-risk patients. N Engl J Med, 2017, 376(14): 1321-1331.
3.	Baumgartner H, Falk V, Bax JJ, et al. 2017 ESC/EACTS guidelines for the management of valvular heart disease. Eur Heart J, 2017, 38(36): 2739-2791.
4.	Nishimura RA, Otto CM, Bonow RO, et al. 2017 AHA/ACC focused update of the 2014 AHA/ACC guideline for the management of patients with valvular heart disease: A report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation, 2017, 135(25): e1159-e1195.
5.	Mack MJ, Leon MB, Thourani VH, et al. Transcatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients. N Engl J Med, 2019, 380(18): 1695-1705.
6.	Hira RS, Vemulapalli S, Li Z, et al. Trends and outcomes of off-label use of transcatheter aortic valve replacement: Insights from the NCDR STS/ACC TVT Registry. JAMA Cardiol, 2017, 2(8): 846-854.
7.	Sievers HH, Schmidtke C. A classification system for the bicuspid aortic valve from 304 surgical specimens. J Thorac Cardiovasc Surg, 2007, 133(5): 1226-1233.
8.	Siu SC, Silversides CK. Bicuspid aortic valve disease. J Am Coll Cardiol, 2010, 55(25): 2789-2800.
9.	van Rosendael PJ, Kamperidis V, Kong WK, et al. Comparison of quantity of calcific deposits by multidetector computed tomography in the aortic valve and coronary arteries. Am J Cardiol, 2016, 118(10): 1533-1538.
10.	Mazur P, Wypasek E, Gawęda B, et al. Stenotic bicuspid and tricuspid aortic valves—Micro-computed tomography and biological indices of calcification. Circ J, 2017, 81(7): 1043-1050.
11.	周达新, 潘文志, 吴永健, 等. 经导管主动脉瓣置换术中国专家共识 (2020更新版). 中国介入心脏病学杂志, 2020, 28(6): 301-309.
12.	Wang J, Deng W, Lv Q, et al. Aortic dilatation in patients with bicuspid aortic valve. Front Physiol, 2021, 12: 615175.
13.	Holmes DR, Brennan JM, Rumsfeld JS, et al. Clinical outcomes at 1 year following transcatheter aortic valve replacement. JAMA, 2015, 313(10): 1019-1028.
14.	Mack MJ, Brennan JM, Brindis R, et al. Outcomes following transcatheter aortic valve replacement in the United States. JAMA, 2013, 310(19): 2069-2077.
15.	Adams DH, Popma JJ, Reardon MJ, et al. Transcatheter aortic-valve replacement with a self-expanding prosthesis. N Engl J Med, 2014, 370(19): 1790-1798.
16.	Yoon SH, Lefèvre T, Ahn JM, et al. Transcatheter aortic valve replacement with early- and new-generation devices in bicuspid aortic valve stenosis. J Am Coll Cardiol, 2016, 68(11): 1195-1205.
17.	Makkar RR, Yoon SH, Leon MB, et al. Association between transcatheter aortic valve replacement for bicuspid vs. tricuspid aortic stenosis and mortality or stroke. JAMA, 2019, 321(22): 2193-2202.
18.	Popma JJ, Deeb GM, Yakubov SJ, et al. Transcatheter aortic-valve replacement with a self-expanding valve in low-risk patients. N Engl J Med, 2019, 380(18): 1706-1715.
19.	Montalto C, Sticchi A, Crimi G, et al. Outcomes after transcatheter aortic valve replacement in bicuspid versus tricuspid anatomy: A systematic review and meta-analysis. JACC Cardiovasc Interv, 2021, 14(19): 2144-2155.
20.	Takagi H, Hari Y, Kawai N, et al. Meta-analysis of transcatheter aortic valve implantation for bicuspid versus tricuspid aortic valves. J Cardiol, 2019, 74(1): 40-48.
21.	Yoon SH, Kim WK, Dhoble A, et al. Bicuspid aortic valve morphology and outcomes after transcatheter aortic valve replacement. J Am Coll Cardiol, 2020, 76(9): 1018-1030.
22.	Pan W, Zhou D, Cheng L, et al. Candidates for transcatheter aortic valve implantation may be fewer in China. Int J Cardiol, 2013, 168(5): e133-e134.
23.	VARC-3 Writing Committee, Généreux P, Piazza N, et al. Valve academic research consortium 3: Updated endpoint definitions for aortic valve clinical research. Eur Heart J, 2021, 42(19): 1825-1857.
24.	Abugroun A, Hallak O, Taha A, et al. In-hospital outcomes of transapical versus surgical aortic valve replacement: From the U. S. national inpatient sample. J Geriatr Cardiol, 2021, 18(9): 702-710.
25.	Kapadia SR, Leon MB, Makkar RR, et al. 5-year outcomes of transcatheter aortic valve replacement compared with standard treatment for patients with inoperable aortic stenosis (PARTNER 1): A randomised controlled trial. Lancet, 2015, 385(9986): 2485-2491.
26.	Pollari F, Dell'Aquila AM, Söhn C, et al. Risk factors for paravalvular leak after transcatheter aortic valve replacement. J Thorac Cardiovasc Surg, 2019, 157(4): 1406-1415.
27.	Salizzoni S, D'Onofrio A, Agrifoglio M, et al. Early and mid-term outcomes of 1904 patients undergoing transcatheter balloon-expandable valve implantation in Italy: Results from the Italian Transcatheter Balloon-Expandable Valve Implantation Registry (ITER). Eur J Cardiothorac Surg, 2016, 50(6): 1139-1148.
28.	Wendler O, Schymik G, Treede H, et al. SOURCE 3 registry: Design and 30-day results of the European postapproval registry of the latest generation of the SAPIEN 3 transcatheter heart valve. Circulation, 2017, 135(12): 1123-1132.
29.	Schaefer A, Plassmeier F, Schofer N, et al. Early commercial experience with a newly designed balloon-expandable transcatheter heart valve: 30-day outcomes and implications of preprocedural computed tomography. Interact Cardiovasc Thorac Surg, 2021, 32(3): 426-432.
30.	Thiele H, Kurz T, Feistritzer HJ, et al. Comparison of newer generation self-expandable vs. balloon-expandable valves in transcatheter aortic valve implantation: The randomized SOLVE-TAVI trial. Eur Heart J, 2020, 41(20): 1890-1899.
31.	Stachon P, Hehn P, Wolf D, et al. In-hospital outcomes of self-expanding and balloon-expandable transcatheter heart valves in Germany. Clin Res Cardiol, 2021, 110(12): 1977-1982.
32.	Xiong TY, Ali WB, Feng Y, et al. Transcatheter aortic valve implantation in patients with bicuspid valve morphology: A roadmap towards standardization. Nat Rev Cardiol, 2023, 20(1): 52-67.
33.	Tchetche D, de Biase C, van Gils L, et al. Bicuspid aortic valve anatomy and relationship with devices: The BAVARD multicenter registry. Circ Cardiovasc Interv, 2019, 12(1): e007107.

1. Leon MB, Smith CR, Mack MJ, et al. Transcatheter or surgical aortic-valve replacement in intermediate-risk patients. N Engl J Med, 2016, 374(17): 1609-1620.
2. Reardon MJ, Mieghem NM, Popma JJ, et al. Surgical or transcatheter aortic-valve replacement in intermediate-risk patients. N Engl J Med, 2017, 376(14): 1321-1331.
3. Baumgartner H, Falk V, Bax JJ, et al. 2017 ESC/EACTS guidelines for the management of valvular heart disease. Eur Heart J, 2017, 38(36): 2739-2791.
4. Nishimura RA, Otto CM, Bonow RO, et al. 2017 AHA/ACC focused update of the 2014 AHA/ACC guideline for the management of patients with valvular heart disease: A report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation, 2017, 135(25): e1159-e1195.
5. Mack MJ, Leon MB, Thourani VH, et al. Transcatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients. N Engl J Med, 2019, 380(18): 1695-1705.
6. Hira RS, Vemulapalli S, Li Z, et al. Trends and outcomes of off-label use of transcatheter aortic valve replacement: Insights from the NCDR STS/ACC TVT Registry. JAMA Cardiol, 2017, 2(8): 846-854.
7. Sievers HH, Schmidtke C. A classification system for the bicuspid aortic valve from 304 surgical specimens. J Thorac Cardiovasc Surg, 2007, 133(5): 1226-1233.
8. Siu SC, Silversides CK. Bicuspid aortic valve disease. J Am Coll Cardiol, 2010, 55(25): 2789-2800.
9. van Rosendael PJ, Kamperidis V, Kong WK, et al. Comparison of quantity of calcific deposits by multidetector computed tomography in the aortic valve and coronary arteries. Am J Cardiol, 2016, 118(10): 1533-1538.
10. Mazur P, Wypasek E, Gawęda B, et al. Stenotic bicuspid and tricuspid aortic valves—Micro-computed tomography and biological indices of calcification. Circ J, 2017, 81(7): 1043-1050.
11. 周达新, 潘文志, 吴永健, 等. 经导管主动脉瓣置换术中国专家共识 (2020更新版). 中国介入心脏病学杂志, 2020, 28(6): 301-309.
12. Wang J, Deng W, Lv Q, et al. Aortic dilatation in patients with bicuspid aortic valve. Front Physiol, 2021, 12: 615175.
13. Holmes DR, Brennan JM, Rumsfeld JS, et al. Clinical outcomes at 1 year following transcatheter aortic valve replacement. JAMA, 2015, 313(10): 1019-1028.
14. Mack MJ, Brennan JM, Brindis R, et al. Outcomes following transcatheter aortic valve replacement in the United States. JAMA, 2013, 310(19): 2069-2077.
15. Adams DH, Popma JJ, Reardon MJ, et al. Transcatheter aortic-valve replacement with a self-expanding prosthesis. N Engl J Med, 2014, 370(19): 1790-1798.
16. Yoon SH, Lefèvre T, Ahn JM, et al. Transcatheter aortic valve replacement with early- and new-generation devices in bicuspid aortic valve stenosis. J Am Coll Cardiol, 2016, 68(11): 1195-1205.
17. Makkar RR, Yoon SH, Leon MB, et al. Association between transcatheter aortic valve replacement for bicuspid vs. tricuspid aortic stenosis and mortality or stroke. JAMA, 2019, 321(22): 2193-2202.
18. Popma JJ, Deeb GM, Yakubov SJ, et al. Transcatheter aortic-valve replacement with a self-expanding valve in low-risk patients. N Engl J Med, 2019, 380(18): 1706-1715.
19. Montalto C, Sticchi A, Crimi G, et al. Outcomes after transcatheter aortic valve replacement in bicuspid versus tricuspid anatomy: A systematic review and meta-analysis. JACC Cardiovasc Interv, 2021, 14(19): 2144-2155.
20. Takagi H, Hari Y, Kawai N, et al. Meta-analysis of transcatheter aortic valve implantation for bicuspid versus tricuspid aortic valves. J Cardiol, 2019, 74(1): 40-48.
21. Yoon SH, Kim WK, Dhoble A, et al. Bicuspid aortic valve morphology and outcomes after transcatheter aortic valve replacement. J Am Coll Cardiol, 2020, 76(9): 1018-1030.
22. Pan W, Zhou D, Cheng L, et al. Candidates for transcatheter aortic valve implantation may be fewer in China. Int J Cardiol, 2013, 168(5): e133-e134.
23. VARC-3 Writing Committee, Généreux P, Piazza N, et al. Valve academic research consortium 3: Updated endpoint definitions for aortic valve clinical research. Eur Heart J, 2021, 42(19): 1825-1857.
24. Abugroun A, Hallak O, Taha A, et al. In-hospital outcomes of transapical versus surgical aortic valve replacement: From the U. S. national inpatient sample. J Geriatr Cardiol, 2021, 18(9): 702-710.
25. Kapadia SR, Leon MB, Makkar RR, et al. 5-year outcomes of transcatheter aortic valve replacement compared with standard treatment for patients with inoperable aortic stenosis (PARTNER 1): A randomised controlled trial. Lancet, 2015, 385(9986): 2485-2491.
26. Pollari F, Dell'Aquila AM, Söhn C, et al. Risk factors for paravalvular leak after transcatheter aortic valve replacement. J Thorac Cardiovasc Surg, 2019, 157(4): 1406-1415.
27. Salizzoni S, D'Onofrio A, Agrifoglio M, et al. Early and mid-term outcomes of 1904 patients undergoing transcatheter balloon-expandable valve implantation in Italy: Results from the Italian Transcatheter Balloon-Expandable Valve Implantation Registry (ITER). Eur J Cardiothorac Surg, 2016, 50(6): 1139-1148.
28. Wendler O, Schymik G, Treede H, et al. SOURCE 3 registry: Design and 30-day results of the European postapproval registry of the latest generation of the SAPIEN 3 transcatheter heart valve. Circulation, 2017, 135(12): 1123-1132.
29. Schaefer A, Plassmeier F, Schofer N, et al. Early commercial experience with a newly designed balloon-expandable transcatheter heart valve: 30-day outcomes and implications of preprocedural computed tomography. Interact Cardiovasc Thorac Surg, 2021, 32(3): 426-432.
30. Thiele H, Kurz T, Feistritzer HJ, et al. Comparison of newer generation self-expandable vs. balloon-expandable valves in transcatheter aortic valve implantation: The randomized SOLVE-TAVI trial. Eur Heart J, 2020, 41(20): 1890-1899.
31. Stachon P, Hehn P, Wolf D, et al. In-hospital outcomes of self-expanding and balloon-expandable transcatheter heart valves in Germany. Clin Res Cardiol, 2021, 110(12): 1977-1982.
32. Xiong TY, Ali WB, Feng Y, et al. Transcatheter aortic valve implantation in patients with bicuspid valve morphology: A roadmap towards standardization. Nat Rev Cardiol, 2023, 20(1): 52-67.
33. Tchetche D, de Biase C, van Gils L, et al. Bicuspid aortic valve anatomy and relationship with devices: The BAVARD multicenter registry. Circ Cardiovasc Interv, 2019, 12(1): e007107.

Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

Transapical transcatheter aortic valve replacement in bicuspid aortic valve patients: In-hospital outcomes

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